MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for VITROS CHEMISTRY PRODUCTS LI SLIDES 1632660 manufactured by Ortho-clinical Diagnostics.
[106604589]
The investigation determined the higher than expected vitros li results were obtained for multiple samples from a single patient processed on a vitros 5600 integrated system. The assignable cause of the event was user error associated with processing lithium testing on the vitros analyzer using a sample tube type (lithium heparin) that is not recommended for use with the vitros lithium assay per the vitros lithium instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[106604590]
The customer obtained higher than expected vitros lithium (li) results for multiple samples drawn from a single patient processed using a vitros 5600 integrated system. Patient sample results of 1. 4 and 1. 7 mmol/l vs. The expected result of 0. 3 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action. The lithium results were reported out of the laboratory and questioned by an emergency room medical professional. It was confirmed that no treatment was altered, initiated or stopped based upon the reported results. It was expected that a corrected report with only the serum lithium result would be sent out. There was no allegation of patient harm as a result of this event. This report is number 2 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00068 |
| MDR Report Key | 7441333 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-11-12 |
| Date Added to Maude | 2018-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS LI SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JIH |
| Date Received | 2018-04-18 |
| Catalog Number | 1632660 |
| Lot Number | 3126-0111-5481 |
| ID Number | 10758750009466 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-18 |